/resources/image/template/step.png ISO 9000

ISO 9000

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The ISO 9000 family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.

Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001.

ISO 9000 series Quality Management Principals

The ISO 9000 series are based on eight quality management principles.

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Principle 3 – Involvement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – System approach to management

Identifying, understanding and managing are interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.

Principle 6 – Continual improvement

Continual improvement of the organization’s overall performance should be a permanent objective of the organization.

Principle 7 – Factual approach to decision making

Effective decisions are based on the analysis of data and information.

Principle 8 – Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Contents of ISO 9001

Outline contents for ISO 9001 are as follows:

  • Page iv: Foreword
  • Pages v to vii: Section 0 Intro
  • Pages 1 to 14: Requirements
  • Section 1: Scope
  • Section 2: Normative Reference
  • Section 3: Terms and definitions
  • Section 4: Quality Management System
  • Section 5: Management Responsibility
  • Section 6: Resource Management
  • Section 7: Product Realization
  • Section 8: Measurement, analysis and improvement
  • Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
  • Page 23: Bibliography

Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed has implemented the requirements of sections 4 to 8. Sections 1 to 3 are not directly audited against, but because they provide context and definitions for the rest of the standard, their contents must be taken into account.

The standard specifies that the organization shall issue and maintain the following six documented procedures:

  • Control of Documents (4.2.3)
  • Control of Records (4.2.4)
  • Internal Audits (8.2.2)
  • Control of Nonconforming Product / Service (8.3)
  • Corrective Action (8.5.2)
  • Preventive Action (8.5.3)

In addition to these procedures, ISO 9001 requires the organization to document any other procedures required for its effective operation. The standard also requires the organization to issue and communicate a documented quality policy, a Quality Manual (which may or may not include the documented procedures) and numerous records, as specified throughout the standard.

Numbering

  • 4.2 Documentation requirements
  • Management responsibility
  • 5.1 Management commitment
  • 5.2 Customer focus
  • 5.3 Quality policy
  • 5.4 Planning
  • 5.5 Responsibility, authority and communication
  • 5.6 Management review
  • 6.0 Resource management
  • 6.1 Provision of resources
  • 6.2 Human resources
  • 6.3 Infrastructure
  • 6.4 Work environment
  • Product realization
  • 7.1 Planning of product realization
  • 7.2 Customer-related processes
  • 7.3 Design and development
  • 7.4 Purchasing
  • 7.5 Production and service provision
  • 7.6 Control of monitoring and measuring equipment
  • Measurement, analysis and improvement
  • 8.1 General
  • 8.2 Monitoring and measurement
  • 8.3 Control of nonconforming product
  • 8.4 Analysis of data
  • 8.5 Improvement


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